Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
NCT ID: NCT04340596
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
118 participants
INTERVENTIONAL
2021-05-21
2026-12-30
Brief Summary
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Detailed Description
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Participants will be screened for eligibility and undergo leukapheresis, and a subset will also undergo optional rectal biopsy and/or lymph node fine needle aspirations (FNAs) (Step 1).
After pre-entry and determination of eligibility in Step 1, participants will be randomized before Step 2 entry to either the N-803 only arm (Arm A) or the N-803 with combination bNAbs arm (Arm B):
* Arm A will receive a dose of N-803, 6 mcg/kg, subcutaneously 1 week after Step 2 entry and then every 3 weeks for a total of eight doses (during the first 22 weeks).
* Arm B will receive the following (during the first 22 weeks):
* Combination bNAb at Step 2 entry with VRC07-523LS dosed at 20 mg/kg and 10-1074 dosed at 30 mg/kg, intravenously;
* A dose of N-803, 6 mcg/kg, subcutaneously 1 week after Step 2 entry and then every 3 weeks for a total of eight doses;
* A second dose of 10-1074 at week 9 of Step 2 dosed at 30 mg/kg, intravenously
After completing randomized treatment (Step 2), participants will interrupt antiretroviral therapy (ART) (Step 3) and will be followed closely to monitor for indications for reinitiation of ART (Step 4).
After Step 2 entry, most participants will be followed for approximately 100 weeks across the remaining three study steps (i.e., Steps 2, 3, and 4).
Step 1 will last up to 90 days, Step 2 will last approximately 52 weeks (study intervention), Step 3 will last up to 24 weeks (ATI), and Step 4 will last 24 weeks (ART restart).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: N-803 only
Participants will receive N-803 6 mcg/kg 1 week after Step 2 entry and then every 3 weeks for a total of eight doses.
N-803 (IL-15 Superagonist)
Administered by subcutaneous (SQ) injection
Arm B: N-803 in combination with 10-1074 and VRC07-523LS
Participants will receive N-803 in combination with 10-1074 and VRC07-523LS as follows:
* At Step 2 entry:
* VRC07-523LS 20 mg/kg
* 10-1074 30 mg/kg
* At Step 2, week 1: N-803 6 mcg/kg every 3 weeks for eight doses
* At Step 2, week 9: 10-1074 30 mg/kg
N-803 (IL-15 Superagonist)
Administered by subcutaneous (SQ) injection
VRC07-523LS
Administered by intravenous (IV) infusion
10-1074
Administered by intravenous (IV) infusion
Interventions
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N-803 (IL-15 Superagonist)
Administered by subcutaneous (SQ) injection
VRC07-523LS
Administered by intravenous (IV) infusion
10-1074
Administered by intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* On ART for at least 96 weeks prior to randomization
* On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization.
* CD4 cell count \>450 cells/mm\^3 within 90 days prior to randomization
* CD4 cell count nadir ≥200 cells/mm\^3.
* Plasma HIV-1 RNA levels of \<50 copies/mL for at least 96 weeks prior to randomization
* Select laboratory results within 90 days of randomization
* IC90 to 10-1074 of ≤1.5 mcg/mL, 10-1074 maximum percent inhibition (MPI) ≥98%, and IC80 to VRC07-523LS of ≤1 mcg/mL on the Monogram PhenoSense assay.
* QTcF interval ≤440 msec within 90 days prior to randomization.
* For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 30 days prior to randomization
* Cisgender women and transgender men of reproductive potential must agree to use two methods of contraception, if participating in sexual activity that could lead to pregnancy.
* Cisgender men and transgender women participants engaging in sexual activity that could lead to pregnancy and who are of reproductive potential must agree to use a barrier method of contraception
* Willingness to abstain from sexual intercourse or use a barrier method of contraception consistently
* Willingness to participate in an ATI.
* Weight \>50 kg and \<115 kg.
* Completion of pre-entry leukapheresis
Exclusion Criteria
* History of or current clinical cardiovascular disease
* Current clinically significant acute or chronic medical condition
* History of HIV-associated neurocognitive disease
* History of an HIV-associated malignancy
* ART initiated during acute HIV infection
* Current receipt of ART other than NRTI and integrase inhibitor.
* Resistance to one or more drugs in two or more ARV drug classes.
* Receipt of any therapeutic HIV vaccine or monoclonal antibody therapy (anti-HIV or otherwise) at any time in the past.
* History of prior immunoglobulin (IgG) therapy.
* History of use of any immunomodulatory medications within 6 months prior to randomization
* Participation in another clinical study of an investigational product currently or within past 12 weeks
* Breastfeeding or pregnancy
18 Years
65 Years
ALL
No
Sponsors
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Rockefeller University
OTHER
ImmunityBio, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Timothy Wilkin, MD, MPH
Role: STUDY_CHAIR
Weill Medical College of Cornell University
Locations
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Alabama CRS (Site ID# 31788)
Birmingham, Alabama, United States
UCLA CARE Center CRS
Los Angeles, California, United States
UCSD Antiviral Research Center CRS (Site ID: 701)
San Diego, California, United States
University of California, San Fransisco HIV/AIDS CRS
San Francisco, California, United States
Whitman-Walker Institute, Inc. CRS (Site ID: 31791)
Washington D.C., District of Columbia, United States
Northwestern University CRS
Chicago, Illinois, United States
Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101)
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
New Jersey Medical School Clinical Research Center CRS [Site ID: 31786]
Newark, New Jersey, United States
Columbia P&S CRS
New York, New York, United States
Weill Cornell Uptown CRS (Site ID: 7803)
New York, New York, United States
Chapel Hill CRS (Site ID: 3201)
Chapel Hill, North Carolina, United States
Case Clinical Research Site
Cleveland, Ohio, United States
Penn Therapeutics, CRS (Site ID: 6201)
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Other Identifiers
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38639
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5386
Identifier Type: -
Identifier Source: org_study_id
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